Patient

P2B-105

completed Phase II

A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma · Delhi State Cancer Institute (Mandoli, India) (Dr. Muller)

consented 2013-04-26

Delhi State Cancer Institute (Mandoli, India)

Adverse events

Serious AEs

Open data queries

Luna dropout signal

—

not on Luna

Adverse events 7

severe serious assessed 2013-09-18

Grade 4 pancytopenia with onset in cycle 6 (2013-09-18); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-09-26.

mild assessed 2013-09-16

Grade 1 anaemia with onset in cycle 6 (2013-09-16); assessed as related to study drug (probable); resolved 2013-10-08.

moderate assessed 2013-08-22

Grade 2 mucosal inflammation with onset in cycle 5 (2013-08-22); assessed as related to study drug (probable); resolved 2013-08-27.

severe serious assessed 2013-08-16

Grade 3 gastritis with onset in cycle 5 (2013-08-16); serious (hospitalization); assessed as not related to study drug (not related); resolved 2013-08-26.

severe serious assessed 2013-08-13

Grade 3 anaemia with onset in cycle 4 (2013-08-13); serious (hospitalization); assessed as related to study drug (probable); resolved 2013-08-29.

moderate assessed 2013-07-14

Grade 2 alopecia with onset in cycle 3 (2013-07-14); assessed as related to study drug (probable); not resolved at last follow-up.

severe assessed 2013-05-24

Grade 3 leukopenia with onset in cycle 1 (2013-05-24); assessed as related to study drug (probable); resolved 2013-06-03; action: drug interrupted.

Data queries 3

SV.occurred_on[V7] open

Visit Cycle 6 Day 1: infusion (last planned cycle) (V7) for P2B-105 occurred on 2013-09-11, 12 d late against planned day 106 (2013-08-30 ± 3 d, anchored on first dose 2013-05-17). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V6] open

Visit Cycle 5 Day 1: infusion; week-12 CT/MRI and ECHO/MUGA before dosing (V6) for P2B-105 occurred on 2013-08-16, 7 d late against planned day 85 (2013-08-09 ± 3 d, anchored on first dose 2013-05-17). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V5] open

Visit Cycle 4 Day 1: infusion (V5) for P2B-105 occurred on 2013-07-27, 8 d late against planned day 64 (2013-07-19 ± 3 d, anchored on first dose 2013-05-17). Confirm the visit date or record a protocol deviation.

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